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Process validation protocol – Operational qualification template

Process validation protocol – Operational qualification template

Use this template to complete the process validation protocol for an operational qualification.

Use this template
or download pdf
Process validation protocol – Operational qualification template

Use this template to complete the process validation protocol for an operational qualification.

Use this template
or download pdf

About the Process validation protocol – Operational qualification template

An Operational Qualification template, also known as an Operational Qualification, is used to complete the process validation protocol by collecting all required data such as calibration equipment, training records and user manuals, and displaying the results of checkpoints, alarms and output data. Use this template to define specific plant/system challenges such as standard conditions and worst-case situations for your validation plan. Lab managers can also take advantage of a customizable Tablet Compression Checklist SOP to ensure that lab personnel take the right steps when using the tablet press.

Related categories

  • Leadership and management templates
  • Quality assurance templates
  • Workplace safety templates
Preview of the template
Process Validation Protocol - Operational Qualification Template
Operational Qualification Protocol
Goal:
Scope of the Operational Qualification Protocol:
Responsibility and responsible person/people/team(s)
Materials, Equipment, Documents
Preparation
List of Calibration Devices/Tools Required
Calibration Process
Calibration Time
Apparatus/Instrument
Document Validation
SOP Name and Number
File Location
QA/QC Approval Date
Training Reports
Name of the emplyee
Select Date and Time:
Course on SOP#
Equipment
Their Make and Model
Is a handbook accessible to everyone?
Results
Control Point(s) and Alarm(s)
Control Point(s) /Alarm(s)
Result
Date
Outputs
Explain the output
Result
Date
Calibration of Equipment/System
Explain the Calibration SOP
Result
Date
Specific Challenge of the Equipment or System
Test in usual conditions
Test of worst case szenario:
Completion
Operational qualification results:
Conclusions:
Name and signature of the protocol author :
Departmental approval by (name and signature):
Quality assurance approval by (name and signature):

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This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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